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目的:建立唑来膦酸的质量标准。方法:参照《中国药典》2005年版,对合成的唑来膦酸理化性质、含量测定等项进行考察并制定质量标准。结果:建立了高效液相色谱法测定唑来膦酸的含量,确定了唑来膦酸的质量标准。结论:该质量标准可有效用于唑来膦酸的质量控制。
Objective: To establish zoledronic acid quality standards. Methods: With reference to “2005 edition of Chinese Pharmacopoeia”, the physical and chemical properties and contents of zoledronic acid synthesized were investigated and the quality standards were established. Results: The HPLC method was established for the determination of zoledronic acid and the quality standard of zoledronic acid was determined. Conclusion: This quality standard can effectively be used for zoledronic acid quality control.